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FDA 510(k)

HILINE™ Fixation System

K-Number: K230565 · 2023-04-20

ApplicantGlobus Medical, Inc.
Decision Date2023-04-20
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HILINE™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K230565. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HILINE™ Fixation System?

HILINE™ Fixation System is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K230565.

When did HILINE™ Fixation System receive FDA 510(k) clearance?

HILINE™ Fixation System received FDA 510(k) clearance on 2023-04-20, under 510(k) number K230565.

Who is the listed applicant for HILINE™ Fixation System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HILINE™ Fixation System?

The FDA product code for HILINE™ Fixation System is OWI.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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